Screw implants for bone fusion

ABSTRACT

Systems, apparatuses and methods for bone fusion are disclosed. In particular, a fixation screw assembly is provided that comprises a bone engagement portion including a shaft and a head member. The assembly also includes a flexible washer member that can be operably attached and secured around the head member of the bone engagement portion. The washer member is polyaxial relative to the bone engagement portion, such that it can assume a variety of angles. The washer member can help prevent back out of the bone engagement portion when the bone engagement portion is implanted into a bone member. The design of the fixation screw assembly can be used in different fusion procedures, including fusion of the sacroiliac joint.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 17/182,453 filed on Feb. 23, 2021 (published as U.S. Pat. Pub.No. 2021-0251672), which is a continuation of U.S. patent applicationSer. No. 16/112,838 filed on Aug. 27, 2018, now U.S. Pat. No.10,925,653, which is a continuation-in-part of U.S. patent applicationSer. No. 15/795,920 filed on Oct. 27, 2017, now U.S. Pat. No.10,335,216, which is a continuation-in-part of U.S. patent applicationSer. No. 14/563,697, filed Dec. 8, 2014, now abandoned, which is acontinuation application of U.S. patent application Ser. No. 13/184,026,filed on Jul. 15, 2011, now abandoned, all of which are hereinincorporated by reference in their entireties for all purposes.

FIELD OF THE INVENTION

The present application generally relates to fixation implants, and inparticular, screw implants.

BACKGROUND OF THE INVENTION

In vertebrate anatomy, the sacrum is a large, triangular bone that liesat the bottom of the lumbar spine, where it connects with the L5vertebra. The sacrum lies adjacent to two hip bones, known as the rightilium and left ilium. The sacrum connects with these bones via jointsknown as sacroiliac joints (or SI joints).

The sacroiliac joints assist in the transmission of forces from thespine to the lower extremities. Degeneration of the sacroiliac jointscan occur due to diseases, such as degenerative sacroiliitis andinflammatory sacroiliitis, as well as due to normal aging and trauma.One type of treatment for a degenerated sacroiliac joint is fusion ofthe joint, which ultimately relieves pain.

Thus, there remains a need for improved implants that assist in thefusion of sacroiliac joints.

SUMMARY OF THE INVENTION

Various fixation implants are provided for assisting in bone fusion. Insome embodiments, an implant for implanting across a sacroiliac joint isprovided. The implant includes a bone engaging portion comprising ashaft and a head portion, wherein the shaft includes a plurality ofthreads. The shaft includes a biomaterial window for receivingbiological material to assist in fusion of the sacroiliac joint. Theimplant further includes a flexible washer member configured to be in alocking configuration around the head portion, wherein the washer memberincludes a plurality of slits that accommodate expansion of the washermember around the head portion and one or more engagement members forengaging a bone surface. The washer member is capable of polyaxialmovement relative to a longitudinal axis of the bone engaging portion.

In some embodiments, an implant for implant across a sacroiliac jointcomprises a bone engaging portion comprising a shaft and a head portion,wherein the shaft includes a plurality of threads. The shaft can have alength of between about 25 mm and 110 mm for extending across at least aportion of an ilium, a sacroiliac joint and sacrum. The implant furtherincludes a flexible washer member configured to be in a lockingconfiguration around the head portion. The washer member is capable ofexpansion around the head portion and includes one or more engagementmembers for engaging a bone surface. The washer member is capable ofpolyaxial movement relative to a longitudinal axis of the boneengagement portion.

According to some embodiments, a fixation screw assembly for fusing asacroiliac joint includes a fixation member and a washer member. Thefixation member includes a head member and a bone-engaging portioncoupled to the head member. The head member having a generally sphericalouter surface and a groove. The washer member has an inner annular lip.The washer member is operatively coupled to the fixation member aroundthe head member. An inner surface of the washer member is generallyspherical and corresponding to the generally spherical outer surface ofthe head member. The washer member is capable of polyaxial movementrelative to a longitudinal axis of the fixation member. When the washermember is sufficiently angled relative to the longitudinal axis of thefixation member, the lip of the washer member bottoms out on the grooveof the head member.

According to yet other embodiments, a fixation screw assembly for fusinga sacroiliac joint includes a fixation member and a washer member. Thefixation member includes a head member and a bone-engaging portionincluding a plurality of threads coupled to the head member. The headmember has a generally spherical outer surface. The bone-engagingportion includes a dual inner diameter including a first portion withshallow threads and a second portion with deep threads. The washermember is operatively coupled to the fixation member around the headmember. An inner surface of the washer member is generally spherical andcorresponds to the generally spherical outer surface of the head member.The washer member is capable of polyaxial movement relative to alongitudinal axis of the fixation member.

In some embodiments, a method of fusing a sacroiliac joint is provided.The method comprises forming an incision in a patient; delivering afixation screw assembly through the incision and laterally toward anilium, wherein the fixation screw assembly includes a washer member anda bone engagement portion comprising a shaft and head member, whereinthe washer member is operatively coupled to the bone engagement portionaround the head member, and wherein the washer member is capable ofpolyaxial movement relative to a longitudinal axis of the boneengagement portion; driving the fixation screw assembly through theilium, across a sacroiliac joint and into a sacrum until the washermember engages a surface of the ilium; and maintaining the fixationscrew assembly in place to assist in fusion of the sacroiliac joint.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a front view of a fixation screw assembly for sacroiliacjoint fusion according to some embodiments.

FIG. 1B is a front view of the fixation screw assembly in FIG. 1A with awasher in a locked configuration according to some embodiments.

FIG. 2 is a close-up cross-sectional view of a washer member angledrelative to the bone-engaging portion according some embodiments.

FIG. 3 is a front view of a fixation screw assembly having a biomaterialwindow according to some embodiments.

FIG. 4 is a front view of a lag screw assembly for sacroiliac jointfusion according to some embodiments.

FIG. 5 is a front view of a lag screw assembly having a biomaterialwindow according to some embodiments.

FIG. 6 illustrates multiple fixation screw assemblies assisting infusion of the sacroiliac joint according to some embodiments.

FIGS. 7A-7F illustrate various view of an alternative embodiment of afixation screw assembly.

FIGS. 8A and 8B illustrate alternative embodiments of a fixation screwassembly.

FIGS. 9A-9E illustrates different embodiments of the positioning ofbiomaterial windows on a shaft of the fixation screw assembly.

FIG. 10 illustrates a screw assembly with an acid etching treatment.

FIGS. 11A-11F illustrates screw assemblies manufactured by variousmethods.

FIGS. 12A-12C illustrate the positioning of the screw assembly withinthe body using different methods.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Detailed embodiments of the invention are disclosed herein; however, itis to be understood that the disclosed embodiments are merely exemplaryof the invention, which may be embodied in various forms. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a basis for the claims and asa representative basis for teaching one skilled in the art to variouslyemploy the present invention in virtually any appropriately detailedstructure.

The present application generally relates to fixation implants, and inparticular, screw implants. The screw implants can be used to assist inthe fusion of the sacroiliac joint. In some embodiments, the screwimplants can be introduced through an ilium, past a degeneratedsacroiliac joint and into the sacrum. After implantation, the screwimplants remain in place and assist in the fusion of the sacroiliacjoint.

One of the difficulties with implanting a screw into a bone member isinadvertent back out. For the ilia, which are wing-shaped, theinadvertent back out of fixation screws presents a challenging problemdue to the curved surfaces. To address this problem, the screw implantsof the present application advantageously provide a mechanism thatprevents or reduces the risk of inadvertent back out from an ilium. Inparticular, the screw implants include an easily assembled washer memberthat assists in preventing inadvertent back out of the screw implant.The washer member is advantageously designed to have flexibility toconform to the ilium contour when the screw implant is implanted in theilium.

FIG. 1A is a front view of a fixation screw assembly for sacroiliacjoint fusion according to some embodiments. The fixation screw assembly5 includes a bone-engaging portion 8 comprising a shaft 10 operablycoupled to a head member 30. The fixation screw assembly 5 also includesa washer member 50 that can be upwardly loaded via the shaft 10 until itis positioned proximate the head member 30. Once proximate the headmember 30, the washer member 50 can be forced upwardly (e.g., using aninstrument) around the head member 30, where it is placed into a lockedconfiguration in which it is securely fastened around the head member30. Once in the locked configuration, the fixation screw assembly 5 canbe inserted into a bone member, such as an ilium, whereby it can assistin fusion (e.g., of the sacroiliac joint).

The shaft 10 of the bone-engaging portion 8 includes a plurality ofthreads 12. As shown in FIG. 1A, the threads 12 extend along at least amajority of the length of the shaft 10. In other embodiments, thethreads 12 extend only along a minority portion of the shaft 10. In someembodiments, the threads 12 of the bone-engaging portion 8 of the shaft10 are dual lead threads, although any type of thread may be used tofacilitate the insertion of bone-engaging portion 8 into bone.

The shaft 10 of the bone-engaging portion 8 also includes a distalportion 14 which serves as the lead end for entry into a bone member.The distal portion 14 can be tapered to assist in the insertion process.In addition, at least one flute can be provided on the distal portion 14or along any other part of the bone-engaging portion 8 in order to clearany chips, dust, or debris generated when the bone-engaging portion 8 isimplanted into bone tissue. In addition, in some embodiments, the shaft10 can be cannulated to receive a guide wire or other type of instrumentto assist in implantation.

In some embodiments, the shaft 10 of the fixation screw assembly 5 isinserted through multiple bone members (e.g., through an ilium andsacrum) to assist in fusion. In order to accommodate insertion throughmultiple bone members, the shaft 10 advantageously has a length ofbetween about 20 mm to about 110 mm, or between about 25 mm to about 110mm. In some embodiments, the shaft 10 of the fixation screw assembly 5also has a diameter or width of between about 6 mm and about 14 mm, orbetween about 8 mm and 12 mm. These ranges advantageously allow biologicmaterial to be packed within the interior of the shaft 10, as discussedin more detail below. As shown in FIGS. 1A and 1B, the shaft 10 of thefixation screw assembly 5 can remain generally constant in diameteralong a majority of the length of the assembly 5, thereby advantageouslyallowing for optimal screw positioning when the bone screw is insertedinto a predetermined area in bone tissue. However, in other embodiments,the shaft 10 can taper, such that its diameter becomes narrower towardsa distal end of the shaft 10.

The shaft 10 is operably connected to a head member 30. The shaft 10transitions into the head member 30 via a neck portion 32. In someembodiments, the neck portion 32 has a diameter or width equal to orless than that of the shaft. Within a top portion 34 of the head member30 is an engagement portion configured to receive a driving instrument,such as a screw driver (not shown). The screw driver can be used todrive the fixation screw assembly 5 into one or more bone members, suchas the ilium and/or sacrum.

The fixation screw assembly 5 includes a washer member 50 that is easilyassembled into a locked configuration with the bone-engaging portion 8.In some embodiments, the washer member 50 resembles a ring-shaped orannular collar having a circular hole that can fit around the shaft 10of the fixation screw assembly 5. The washer member 50 can be slidablymoved up and down the shaft 10 until it is locked around the head member30. The washer member 50 includes one or more slits 52 that canaccommodate expansion of the washer member 50 over the head member 30,thereby placing the washer member 50 in an assembled and lockedconfiguration around the head member 30. In some embodiments, the washermember 50 is pre-assembled in a locked configuration around the headmember 30 of the fixation screw assembly 5 (as shown in FIG. 1B). On anend of the washer member 50 opposite from the slits 52, the washermember 50 includes one or more engagement surfaces or teeth 54 that canengage a surface of a bone member (e.g., an ilium) when the fixationscrew assembly 5 is implanted into bone.

Advantageously, the washer member 50 is flexible and polyaxial relativeto the bone-engaging portion 8. In other words, the washer member 50 canbe angled, rotated or swiveled in multiple directions, as best shown inFIG. 2 . In some embodiments, the washer member 50 can have a centralaxis that is positioned at an angle of between about 0 and about 30degrees, or between about 0 and 24 degrees, relative to the longitudinalaxis of the bone-engaging portion 8.

The components of the fixation screw assembly 5 can be composed ofvarious biocompatible materials. The materials include, but are notlimited to, stainless steel, alloys, titanium, titanium based alloys orpolymeric materials.

In operation, when a lateral compressive force is applied to thefixation screw assembly 5, the bone-engaging portion 8 is driven througha bone member, such as the ilium. As the bone-engaging portion 8 isdriven laterally, the washer member 50 also engages a surface of thebone member (as shown in FIG. 6 ). The washer member 50 can engage thebone member at a different angle from the bone-engaging portion 8. Thisrelative angulation advantageously allows the washer member 50 to engagea curved surface of a bone member (e.g., the ilium) with ease, even whenthe bone-engaging portion 8 is at a different angle. Furthermore, thecompressive force of an angled washer member 50 against the head member30 of the bone-engaging portion 8 also advantageously prevents back outof an implanted fixation screw assembly 5.

FIG. 2 is a close-up cross-sectional view of a washer member angledrelative to the bone-engaging portion according some embodiments. Fromthis view, the angulation of the washer member 50 relative to the headmember 30 of the bone-engaging portion 8 is visible. Also, the physicalinterface 76 between the washer member 50 and the head member 30 is alsoshown. When a force is applied, the washer member 50 will be placed in acompressive force with the head member 30 at the interface 76, therebyhelping to prevent inadvertent back out of the bone-engaging portion 8from a bone member.

FIG. 3 is a front view of a fixation screw assembly having a biomaterialwindow according to some embodiments. The fixation screw assembly 5 issimilar to the assembly in FIGS. 1A and 1B, except that it also includesa biomaterial window 16. Biological material, including natural andsynthetic material, can be inserted into the biomaterial window 16 toassist in bone growth and fusion. In some embodiments, the biologicalmaterial comprises a rectangular window, as shown in the illustratedembodiment. The biomaterial window advantageously has a length ofbetween about ¼ to ⅘ of the length of the shaft 10, such that it canexpand across multiple bone members and/or joints if desired. In someembodiments, the biomaterial window has a length of between about ⅓ to ½of the length of the shaft 10.

FIG. 4 is a front view of a lag screw assembly for sacroiliac jointfusion according to some embodiments. The lag screw assembly 15 includesmany of the features of the fixation screw assembly 5 in FIG. 1 ,including a bone-engaging portion 8, a head portion and a washer 50configured to lock around the head portion. However, unlike the fixationscrew assembly 5, the lag screw assembly 15 further includes asubstantially smooth, non-threaded portion 80 that extends between thebone-engaging portion 8 and the head portion. In some embodiments, thethreaded portion and the non-threaded portion of the lag screw assemblyform a continuous, monolithic component.

FIG. 5 is a front view of a lag screw assembly having a biomaterialwindow according to some embodiments. As shown in the illustratedfigure, the lag screw assembly 15 includes a biomaterial window 16through which biologic material can be deposited. Advantageously, thelag screw assembly 15 can be designed such that the biomaterial window16 extends across both the threaded portion and the non-threaded portion80. In other embodiments, the biomaterial window 16 need only extendwithin the non-threaded portion 80, such that the threads of the lagscrew assembly remain intact. However, one skilled in the art willappreciate that the biomaterial window can also extend into the threadedportion of the bone-engaging portion 8 if desired.

FIGS. 7A-7E depict an alternative embodiment of a fixation screwassembly 105 for sacroiliac joint fusion according to other embodiments.Fixation screw assembly 105 is similar to the fixation assembliespreviously discussed. Therefore, like features will be described withreference to similar numeral indicators. The fixation screw assembly 105may be especially suitable as a sacroiliac fusion screw and is intendedto increase the fixation achieved in sacroiliac fusion while decreasingthe chance of migration. The sacroiliac fixation screw assembly 105 maybe placed across the sacroiliac joint, and may traverse varying bonequality, including soft cancellous bone of the sacrum and hard corticalbone of the iliac wings. Oftentimes bone screws do not address thedrastic change in bone quality between sacrum and ilium causing haloingof screws on the sacral cancellous side. The fixation screw assembly 105described herein including a dual inner diameter offers varying threadforms to address varying bone quality. In addition, the screw profilemaximizes bone purchase when placed from a cortical to cancellousanatomy. Although generally described with reference to sacroiliacfusion, it will be appreciated that the fixation screw assembly 105 maybe utilized for other bone screw applications.

FIG. 7A provides a perspective view of the assembly 105. The fixationscrew assembly 105 includes a fixation member 102 and a washer member150. The fixation member 102 extends from a proximal portion 104 to adistal portion 114. The fixation member 102 includes a bone-engagingportion 108 including a plurality of threads 112. The fixation member102 comprises a shank or shaft 110 operably coupled to a head member130, for example, through a neck portion 132. The head member 30includes an engagement portion 34. The engagement portion 34 may includean internally threaded portion and/or a socket portion (e.g.,hexalobular), configured to receive a driving instrument, such as ascrew driver (not shown). The screw driver can be used to drive thefixation screw assembly 105 into one or more bone members, such as theilium and/or sacrum. The hexalobular driving feature may help to preventstripping of the screw or instrument stripping especially because thefixation member 102 is going through hard cortical bone requiring largeforces to drive the screw.

In this embodiment, the shaft 110 is cannulated with an opening 106extending from the proximal portion 104 to the distal portion 114 of thefixation member 102, and may thereby receive a guide wire or other typeof instrument to assist in implantation. When cannulated, the fixationassembly 105 may be inserted in a minimally invasive fashion.

The shaft 110 may include one or more biomaterial slots or windows 116,118. The biomaterial windows 116, 118 may be filled with bone graft andcross either the sacroiliac joint for fusion or enhance fusion andprevent migration of the screw especially for longer screw lengths. Afirst biomaterial window 116 is similar to biomaterial window 16discussed previously. As best seen in the cross-sectional view shown inFIG. 7E, a second biomaterial window 118 is provided closer to thedistal portion 114 and is offset 90 degrees relative to the firstbiomaterial window 116. The biomaterial windows 116, 118 may beelongated having a length extending along the longitudinal axis of thedevice 102 greater than its respective width. The biomaterial windows116, 118 are each in fluid communication with the cannulated opening106. The biomaterial slots or windows 116, 118 may be filled with bonegraft material, and are located along the length of the screw to therebycross the sacroiliac joint for fusion. Additional windows 116, 118 befilled with bone graft to enhance fusion and prevent migration of thedevice 105 especially for longer screw lengths.

As best seen in the close-up perspective view in FIG. 7C and theclose-up cross-sectional view in FIG. 7D, the shaft 110 of the fixationmember 102 may include a dual inner diameter. A dual inner diameterscrew 102 provides for shallow threads 124 and deep threads 126 with aconstant pitch 128 and constant outer diameter on two regions of thebone screw shaft 110. The portion of threads 112 at the proximal portion104 of the screw 102 (intended to fixate cortical bone) has shallowthreads 124 while the portion of threads 112 at the distal tip of thescrew 102 (intended to fixate cancellous bone) has deep threads 126. Thedeep threads 126 combined with the consistency in pitch 128 allow formore bone to be located within the deep threads 126 than within theshallow threads 124, thereby providing increased bone purchase,increased resistance to pullout, and/or increased resistance tomigration in softer less dense bone. The dual inner diameter thread mayprovide for increased fixation, decreased migration, decreased pullout,and decreased haloing of the device 105. This is advantageous when thereis a drastic change in bone quality at various parts along the screwlength. The feature of varying inner diameter with a constant outerdiameter allows for shallow threads 124 at the proximal portion 104 anddeep threads 126 at the distal portion 114, which may be ideal forcrossing from cortical to cancellous bone.

The fixation screw assembly 105 also includes a washer member 150. Thewasher member 150 may resemble a ring-shaped or annular collar having acircular hole that can fit around the head member 130 of the fixationscrew assembly 105. An inner surface of the washer member 150 may besubstantially spherical and may correspond to a substantially sphericalouter surface of the head member 130, thereby allowing for polyaxialrotation. Angulation may be needed when the fixation member 102 isimplanted laterally because the anatomy of the iliac wings is sloped andmay vary drastically between patients.

The washer member 150 may have an inner annular lip 152. As best seen inthe close-up cross section shown in FIG. 7B, when the washer member 150is angled, a portion of the lip 152 on the top of the washer member 150bottoms out on a groove 136 on the top of the spherical head member 130.The lip 152 on the washer member 150 coupled with the groove 136 on thescrew head 130 may allow for maximum angulation while maintaining aportion of the washer member 150 below the equator of the screw shank110 to prevent disassembly during implantation. Angulation may beimportant when the sacroiliac screw is implanted laterally toaccommodate varying anatomy of the iliac wing. If only minimalangulation were provided by the implant, it is possible that a portionof the washer would not be seated in bone and would be free-floating insoft tissue.

The washer member 150 can be angled, rotated or swiveled in multipledirections. The washer member 150 can be slidably moved up and down theshaft 110 until it is locked around the head member 130. The washermember 150 may include one or more engagement surfaces or teeth 154 thatcan engage a surface of a bone member (e.g., an ilium) when the fixationscrew assembly 1055 is implanted into bone. The teeth 154 may beprovided on the bottom of the washer member 150 to grip into bone andprovide tactile feedback to the user. The bottom teeth 154 of the washermember 150 may be tapered inward to allow the teeth 154 of the washermember 150 to recess into bone to provide a lower profile implant andmaintain tactile feedback. Similarly, the bottom outside outer surfaceof the washer member 150 may be tapered inward to allow the teeth 154 ofthe washer member 150 to sometimes recess into bone to provide a lowerprofile implant but maintain tactile feedback. The outer diameter of thewasher member 150 is larger than the outer diameter of the head member130 so a portion of the washer teeth 154 always contact bone. The washermember 150 may be assembled onto the fixation member 102 from the top ofthe fixation member 102 to prevent disassembly of the washer member 150from the fixation member if the assembly 105 is removed afterimplantation. In this manner, the washer member 150 cannot disassemblefrom the screw shank 110 during removal since the washer member 150 isassembled onto the screw shank 110 from the top.

FIG. 7F illustrates another embodiment of a washer member 151 in a crosssectional view. The washer member 151 can be slidably moved up and downthe shaft 111 until it is locked around the head member 131. The washermember 151 may include one or more engagement surfaces or teeth 153 thatcan engage a surface of a bone member (e.g., an ilium) when the fixationscrew assembly is implanted into bone. The teeth 153 may be provided onthe bottom of the washer member 151 to grip into bone and providetactile feedback to the user. The bottom teeth 153 of the washer member150 may be tapered inward to allow the teeth 153 of the washer member151 to recess into bone to provide a lower profile implant and maintaintactile feedback. Similarly, the bottom outside outer surface of thewasher member 151 may be tapered inward to allow the teeth 153 of thewasher member 151 to recess into bone to provide a lower profile implantbut maintain tactile feedback. The configuration of the washer member151 allows for extreme angulation. A portion of the washer member isconfigured to always remain below the equator of the screw head whenmaximum angulation is achieved to prevent disassembly duringimplantation. The teeth 153 on the bottom surface of the washer member151 also provides tactile feedback to the user. The outer diameter ofthe washer member is larger than the outer diameter of the screw so aportion of the washer teeth 153 always contact bone.

Similar to assembly 105, the components of the fixation screw assembly105 can be composed of various biocompatible materials. The materialsinclude, but are not limited to, stainless steel, alloys, titanium,titanium based alloys or polymeric materials. The components of thefixation screw assembly 105 can be coated, roughened, or otherwisetreated to improve osseointegration. The implant can be driven andinserted by traditional methods, image guided methods, or other usingother minimally invasive procedures. The fixation screw assembly 105 maybe implanted laterally or posteriorly, for example, to achieve asacroiliac joint fusion.

In another embodiment as shown in FIG. 8A, the screw assembly 160 mayinclude one or more biomaterial slots or windows 162, 164, 166. Thebiomaterial windows 162, 164, 166 may be filled with bone graft andcross either the sacroiliac joint for fusion or enhance fusion andprevent migration of the screw especially for longer screw lengths. Asbest seen in the cross-sectional view shown in FIG. 8A, a secondbiomaterial window 164 is provided closer to the distal portion and isoffset 90 degrees relative to the first biomaterial window 162. A thirdbiomaterial window 166 is provided even closer to the distal end of theshaft and configured to have a smaller diameter than the first andsecond biomaterial windows. The biomaterial windows 162, 164, 166 may beelongated having a length extending along the longitudinal axis of thedevice greater than its respective width. The biomaterial windows 162,164, 166 are each in fluid communication with the cannulated opening.The biomaterial slots or windows 162, 164, 166 may be filled with bonegraft material, and are located along the length of the screw to therebycross the sacroiliac joint for fusion. The biomaterial windows geometryis configured such that there is no gap between adjacent fusion areas.Since the sacroiliac joint is extremely variable in every patient andminimal in width, ensuring the fusion area crosses the joint requires nogap between adjacent fusion areas. In order to not compromise the screwsstrength, adjacent biomaterial windows are placed perpendicular to eachother and are tapered in the overlapping section to maintain as muchcross-sectional area as possible.

FIG. 8B illustrates yet another embodiment of the screw assembly 168. Inthis embodiment the shaft is provided with two biomaterial windows 170,172. The first biomaterial window 170 is positioned closer to the screwhead 174 and the second biomaterial window 172 is positioned closer tothe distal end of the shaft 176. The first and second biomaterialwindows are perpendicular to one another and overlap. The shaft of thescrew assembly is also cannulated. FIGS. 9A-9E illustrate differentconfigurations of the biomaterial windows on the shaft of screwassembly. FIG. 9A illustrates a shaft of screw assembly with threebiomaterial windows, with two of the biomaterial windows in a firstplane and a third biomaterial window offset by 90 degrees and configuredto overlap with the first and second biomaterial windows. FIG. 9Billustrates an embodiment in the which the shaft of a screw assembly isprovided with a one elongated biomaterial window and two smallercircular or oval windows in a first plane. This embodiment also providesthree additional circular or oval windows offset by 90 degrees form thefirst plane and configured to overlap the two circular windows of thefirst plane. FIG. 9C illustrates a shaft of a screw assembly having afirst bullet nosed biomaterial window in a first plane and a secondbullet nosed biomaterial window in a second plane offset by 90 degrees.The first bullet nosed biomaterial window and the second bullet nosedbiomaterial window are configured to overlap with one another. FIGS. 9Dand 9E are additional embodiments of a shaft of a screw assembly with afirst and second biomaterial window offset by 90 degrees andoverlapping. More specifically, as illustrated in FIGS. 9A, 9C and 9E,the biomaterial windows may be tapered. It should be noted thebiomaterial window may be formed in any shape that would allow bonegrowth.

The overlapping geometry of the biomaterial windows ensure that thefusion area will cross the joint regardless of insertion point ortrajectory. The multiple fusion areas are intended to increase thechance of fusion along the length of the screw to decrease screwmigration. This is advantageous to accommodate various patient anatomy,various bone quality, and various trajectories. The shaft of the screwassembly may also include several overlapping perpendicular slotsintended to be filled with bone graft and cross either the sacroiliacjoint for fusion or enhance fusion and prevent migration of the screwespecially for longer screw lengths. The screw assemblies as illustratedin FIGS. 8A and 8B are also cannulated.

FIG. 10 illustrates a screw assembly that is configured with a laserengraving treatment. A nanotube treatment may be added to the screw toimprove osseointegration and antimicrobial properties. The subtractivetreatments may also be applied to the minor diameter of the threads asto not compromise structural integrity of the screw. The treatment maybe offset from the sharp edges of the biomaterial windows to reduce thelikelihood of crack propagation. The subtractive treatment may beapplied along the entire length of the screw or only at the portion ofthe screw that comes in contact with sacral bone. The subtractivetreatment may be omitted near the slotted portion of the screw.

FIGS. 11A-11F illustrates the screw assembly manufactures by variousmethods. Specifically, FIG. 11A illustrates the screw assembly is amachined assembled screw. FIG. 11B is an acid etched screw. FIG. 11C isa machined screw with laser engravings. FIG. 11D is a machined screwthat includes 3D printed bone plugs positioned within the biomaterialwindows. FIG. 11E is a 3D printed screw. FIG. 11F is a 3D printed dowelwith 3D printed porous plug that is positioned within the biomaterialwindows.

Methods

The fixation screw assemblies and/or lag screw assemblies describedabove can be used in various surgical methods, and in particular, thoseinvolving fusion of the sacroiliac joint. The screw assemblies can beinserted minimally invasively, and can be inserted using one or morepercutaneous delivery instruments.

In some embodiments, the application encompasses surgical methodsincluding:

-   -   a. forming an incision in a patient, wherein the incision has a        width of between about 7 mm and 33 mm;    -   b. inserting a guide sleeve percutaneously through the incision        to provide a lateral approach for inserting a fixation screw        assembly;    -   c. inserting a fixation screw assembly through the guide sleeve,        wherein the fixation screw assembly includes a flexible washer        member and a bone engagement portion comprising a shaft and head        portion, wherein the washer member is pre-assembled in a locked        configuration around the head portion, and wherein the washer        member is configured to move polyaxially relative to the shaft        and head portion;    -   d. using a screw driver to drive the fixation screw assembly        through an ilium, sacroiliac joint and sacrum;    -   e. driving the fixation screw assembly through the bone members        until the washer member compresses against a surface of the        ilium, thereby helping to prevent back out of the fixation        screw;    -   f. maintaining the fixation screw in place to assist in fusion        of the sacroiliac joint.

The process described above can be repeated multiple times until two,three or more fixation screw assemblies are deposited across thesacroiliac joint. Advantageously, in some embodiments, at least twofixation screw assemblies are provided to stabilize and assist in thefusion of the sacroiliac joint. In some embodiments, at least threefixation screw assemblies are provided, as shown in FIG. 6 . As shown inthe illustrated embodiment, the fixation screw assemblies 5 a, 5 b, and5 c can include bone engagement portions 8 having shafts 10 of variablelengths. For example, while fixation screw assemblies 5 a and 5 c haveshafts 10 that are long enough to be implanted through a portion of anilium 7, sacroiliac joint 11 and sacrum 9, fixation screw assembly 5 bhas a relatively shorter shaft that passes only through a portion of theilium 7.

While the process detailed above describes a lateral approach, oneskilled in the art will appreciate that insertion of the fixation screwassembly and/or lag screw assemblies can be performed via otherapproaches as well, including anteriorly and posteriorly. For instance,FIGS. 12A, 12B, and 12C illustrate different approaches for positioningthe screw assembly. FIG. 12A illustrates a method in which the screwassembly is positioned in a lateral approach. FIG. 12B illustrates amethod in which the screw assembly is positioned in a posterior approachplacing the screw assembly medial to lateral and FIG. 12C illustrates amethod in which the screw is positioned with a posterior approachplacing the screw lateral to medial. In addition, the processesencompassed by this application are not limited to the steps describedabove. For example, an additional step can be provided in which biologicmaterial is introduced into the fixation screw assembly (e.g., via abiomaterial window), thereby aiding in the fusion of the sacroiliacjoint.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present inventionwithout departing from the scope or spirit of the invention. Moreover,the improved implants and related methods of use need not feature all ofthe objects, advantages, features and aspects discussed above. Thus, forexample, those skilled in the art will recognize that the invention canbe embodied or carried out in a manner that achieves or optimizes oneadvantage or a group of advantages as taught herein without necessarilyachieving other objects or advantages as may be taught or suggestedherein. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications and methods ofuse, which are within the scope of this invention, will be readilyapparent to those of skill in the art based upon this disclosure. It iscontemplated that various combinations or subcombinations of thesespecific features and aspects of embodiments may be made and still fallwithin the scope of the invention. Accordingly, it should be understoodthat various features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the discussed spacer implants. Thus, it is intended that thepresent invention cover the modifications and variations of thisinvention provided that they come within the scope of the appendedclaims or their equivalents.

What is claimed is:
 1. A method for fusing a sacroiliac jointcomprising: providing a fixation screw assembly, the fixation screwassembly including: a bone screw including a head and a shank coupled tothe head to define a longitudinal axis of the bone screw, the headhaving a generally spherical outer surface defining an equator plane,the shank including a first biomaterial window and a second biomaterialwindow, the first biomaterial window and the second biomaterial windowbeing circumferentially offset from each other and at least partiallyoverlapping longitudinally; and a washer disposed around the bone screwhead, an inner surface of the washer being generally spherical andcorresponding to the generally spherical outer surface of the head forpolyaxial movement around the head relative to the longitudinal axis ofthe bone screw, wherein at least a portion of the washer is positionedbelow the equator plane at any polyaxial angle of the washer relative tothe longitudinal axis of the bone screw; forming an incision in apatient; inserting a guide sleeve in a patient; inserting the fixationscrew assembly through the guide sleeve; and driving the fixation screwassembly into a bone of the patient.
 2. The method of claim 1, whereinthe washer includes a plurality of teeth configured to directly engagethe bone.
 3. The method of claim 1, wherein the first and secondbiomaterial windows are disposed circumferentially perpendicular to oneanother.
 4. The method of claim 1, wherein the shaft includes a thirdbiomaterial window offset 90 degrees relative to the first biomaterialwindow.
 5. The method of claim 1, wherein the bone screw is cannulatedand has a cannulated opening at a proximal end of the shank, and thefirst and second biomaterial windows are each in fluid communicationwith the cannulated opening.
 6. The method of claim 5, wherein the bonescrew includes a dual inner diameter including a first portion withshallow threads and a second portion with deep threads.
 7. The method ofclaim 1, wherein the bone screw is a 3D printed bone screw.
 8. Themethod of claim 1, wherein the washer is configured to be angled,rotated or swiveled in multiple directions.
 9. The method of claim 2,wherein the teeth are tapered inward to allow the teeth to recess intothe bone.
 10. The method of claim 1, wherein the bone screw includes adual inner diameter including a first portion with shallow threads and asecond portion with deep threads.
 11. A method for fusing a sacroiliacjoint comprising: providing a fixation screw assembly, the fixationscrew assembly including: a bone screw including a head and a shankincluding a plurality of threads coupled to the head to define alongitudinal axis of the bone screw, the head having a generallyspherical outer surface defining an equator plane, the shank including afirst biomaterial window and a second biomaterial window, the firstbiomaterial window and the second biomaterial window beingcircumferentially offset from each other and at least partiallyoverlapping longitudinally, wherein the shank includes a dual innerdiameter including a first portion with shallow threads and a secondportion with deep threads; and a washer disposed around the head of thebone screw, an inner surface of the washer being generally spherical andcorresponding to the generally spherical outer surface of the head forpolyaxial movement relative to the longitudinal axis of the bone screw,wherein at least a portion of the washer is positioned below the equatorplane at any polyaxial angle of the washer relative to the longitudinalaxis of the bone screw; forming an incision in a patient; inserting aguide sleeve in a patient; inserting the fixation screw assembly throughthe guide sleeve; and driving the fixation screw assembly into a bone ofthe patient.
 12. The method of claim 10, wherein the bone screw iscannulated with an opening extending from a proximal portion to a distalportion of the bone screw.
 13. The method of claim 10, wherein the shaftincludes a third biomaterial window circumferentially offset 90 degreesrelative to the second biomaterial window and overlaps the secondbiomaterial window longitudinally.
 14. The method of claim 13, whereinthe bone screw is cannulated and has a cannulated opening at a proximalend of the shank, and the first, second and third biomaterial windowsare each in fluid communication with the cannulated opening.
 15. Themethod of claim 11, wherein the head of the bone screw includes a grooveat a proximal-most end of the head and the washer includes a lip at aproximal-most end of the washer.
 16. The method of claim 15, whereinwhen the washer is sufficiently angled relative to the longitudinal axisof the bone screw, the lip of the washer bottoms out on the groove ofthe head.
 17. The method of claim 11, wherein the bone screw is a 3Dprinted bone screw.
 18. The method of claim 11, wherein the washer isconfigured to be angled, rotated or swiveled in multiple directions. 19.The method of claim 11, wherein the washer includes one or moreengagement surfaces configured to engage the bone.
 20. The method ofclaim 19, wherein the engagement surfaces are teeth that are taperedinward to allow the teeth to recess into bone.